Optetrak Unicondylar 252-12-02

GUDID 10885862065766

Exactech, Inc.

Uncoated unicondylar knee tibia prosthesis, polyethylene

• Primary Device ID: 10885862065766
• NIH Device Record Key: 3fb113c4-b488-4d10-bcff-5aedf4f01d53
• Commercial Distribution Discontinuation: 2021-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Optetrak Unicondylar
• Version Model Number: 252-12-02
• Catalog Number: 252-12-02
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862065766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040889

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-09-01
• Device Publish Date: 2015-10-30